Immobilization During Peripheral Venous Catheter Placement
1 other identifier
interventional
322
1 country
1
Brief Summary
Aim: To determine the most effective type of upper limb immobilization in the cannulation of a peripheral venous line in the pediatric emergency department. Methods: Randomized clinical trial with 322 patients conducted in a tertiary pediatric emergency. The impact of two types of restraints (immobilization of the elbow joint versus arm restraint, without immobilization of the elbow joint) on the success of the technique was analyzed. Multivariate analysis was used to analyze the impact of other variables (weight, age, movements, pain) on the success of the technique.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 28, 2023
CompletedFirst Submitted
Initial submission to the registry
August 29, 2025
CompletedFirst Posted
Study publicly available on registry
September 19, 2025
CompletedSeptember 19, 2025
September 1, 2025
9 months
August 29, 2025
September 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
success of peripheral venous line cannulation on the first attempt
Percentage of successful cannulations on the first attempt, as assessed by the registered nurse.
From enrollment to the end of the procedure (15 minutes)
Secondary Outcomes (3)
Number of attempts required
From enrollment to the end of the procedure (15 minutes)
Time to successful catheterization
From start of procedure until catheter placement (≤15 minutes)
Nurse's assessment of patient's pain
Immediately after procedure
Study Arms (2)
elbow joint immobilization
EXPERIMENTALPediatric patients undergo cannulation of a peripheral venous line with immobilization of the elbow joint
arm restraint without immobilization of the elbow joint
ACTIVE COMPARATORPediatric patients undergo cannulation of a peripheral venous line with arm restraint, but the elbow joint is not immobilized.
Interventions
Immobilization of the elbow joint during peripheral venous line cannulation in pediatric patients on the success of the technique
Use of arm restraint without immobilization of the elbow joint during peripheral venous line cannulation in pediatric patients.
Eligibility Criteria
You may qualify if:
- Pediatric patients at emergency department that need a peripheral venous line
You may not qualify if:
- Critically ill patient
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Universitario La Paz
Madrid, Madrid, 28022, Spain
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
August 29, 2025
First Posted
September 19, 2025
Study Start
June 1, 2022
Primary Completion
March 1, 2023
Study Completion
March 28, 2023
Last Updated
September 19, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share
Individual participant data (IPD) will not be shared because the study involves a small sample of pediatric patients in a single hospital. Sharing the data could compromise confidentiality despite de-identification, and the main outcomes will be disseminated through peer-reviewed publications and conference presentations.